By Rose Pagano and Suzanne M. Sensabaugh, MS, MBA

 

Time is money, and to help you save both time and money the FDA recently released a revised version of their Guidance for Industry on Formal Meetings between the FDA and Biosimilar Biological Product Sponsors or Applicants (November 2015). Here are some of the major revisions to the document.

Major changes in the recently released Guidance for Industry “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products” entail the addition of WRO meetings, precise details about paper submissions, a timeline of receiving preliminary comments from FDA, and the process of contacting the FDA project manager regarding disagreements about the meeting minutes.

Regarding potential meeting formats with the FDA, a new option is WRO, also known as Written Response Only. This variety of meeting is available to applicants interested in a Biosimilar Initial Advice (BIA) meeting in order to have an initial assessment on licensure through § 351 (k) of the Public Health Service (PHS) Act. A WRO is also an option for Biological Product Development (BPD) Type 2 meetings that intend to discuss a particular issue in an ongoing development program.

The new document also clarifies that paper submissions for meeting requests and packages are still an option as long as they are sent to the appropriate review division. Paper (desk copies) is still recommended for the Center for Drug Evaluation and Research (CDER), but not for the Center for Biologics Evaluation and Research (CBER).

According to the revised document, you should expect to receive preliminary responses to the questions asked two to five business days before the meeting, but note that these responses are not the final feedback. As in the previous version of this Guideline, if this feedback generates new ideas for the product or additional topics for the meetings, this information will not be reviewed by the FDA when you do meet since it was not presented in the initial application.

Furthermore, meetings are denied when they are not granted. Also, the revised document states that the FDA will record the meeting minutes that will serve as a general outline of the meeting. If there is a disagreement concerning these minutes, the requester should contact the FDA project manager to address these issues.

Additionally, there is more detail concerning the BSUFA fees related to the BPD program. These fees typically include both the initial and annual BPD fee as well as a reactivation payment. Remember, failing to pay these fees in the designated amount of time will result in the FDA canceling the BPD meeting.

All in all, this revised document is a lot more reader-friendly and should serve as your ultimate how-to guide when it comes to scheduling, preparing, and attending BsUFA meetings with the FDA. By following the FDA’s recommendations, you will surely be successful with your biosimilars!

WE CAN HELP YOU HAVE SUCCESSFUL BsUFA MEETINGS WITH THE FDA

We meet with the FDA to discuss biosimilar and interchangeable products on a regular basis. Do you need to have a BsUFA meeting with the FDA? Do you need help identifying the correct Review Division for your biosimilar or interchangeable product? Do you need help preparing your meeting materials? Contact us today to learn more about our services and how we can help you.

 

Suzanne Sensabaugh

Suzanne M. Sensabaugh has advanced the development of over 130 biologics, biosimilars, and combination products since 2009. She can be reached at smsensabaugh@hw-fda.com